小儿肺热咳喘颗粒中3种主要成分含量测定的HPLC与UHPLC的方法转换  

Method Conversion between HPLC and UHPLC for Determination of Three Main Components in Xiao'er Feire Kechuan Keli

作　　者：刘萍 林方领 王伟 何明玉 余彦海 Liu Ping;Lin Fangling;Wang Wei;He Mingyu;Yu Yanhai(Hainan Huluwa Pharmaceutical Group Co.,Ltd.,Haikou 570312,China;Agilent Technologies Co.Ltd(China)Guangzhou Branch Company,Guangzhou 510030,China)

机构地区：[1]海南葫芦娃药业集团股份有限公司,海口570312 [2]安捷伦科技(中国)公司广州分公司,广州510030

出　　处：《实验与分析》2025年第1期29-34,共6页LABOR PRAXIS

摘　　要：为建立将小儿肺热咳喘颗粒中麻黄、黄芩苷和连翘苷3种主要成分含量测定的HPLC方法转换成UHPLC的方法。文章根据《中国药典》2020版四部通则0512液相色谱法(后简称为0512通则)关于HPLC转UHPLC的规定进行合规转换。结果显示UHPLC方法下,麻黄、黄芩苷和连翘苷的线性关系良好,相关系数r≥0.999,回收率在95%-100%之间,方法学验证结果符合接受标准,含量测定结果与HPLC基本一致。与常规HPLC方法相比,UHPLC的方法可以大幅缩短分析时间,提高分析效率,且减少溶剂消耗,绿色环保。To establish a method conversion between HPLC and UHPLC for determination of three main components(ephedra,baicalin,and phillyrin)in Xiao'er Feire Kechuan Keli.According to the regulations on HPLC to UHPLC conversion in section 0512 of the 2020 Pharmacopoeia Part IV General Principles,compliance conversion was carried out.Under the UHPLC method,the linear relationship of ephedra,baicalin,and phillyrin was good,with a correlation coefficient(r)≥0.999 and the recovery between 95%and 100%.The methodological validation results met the acceptance criteria,and the determination results were basically consistent with HPLC.Compared with conventional HPLC methods,the UHPLC method can significantly shorten analysis time,improve analysis efficiency,and consume less solvent,make environmentally friendly.

关 键 词：超高效液相色谱法(UHPLC) 高效液相色谱法(HPLC) 小儿肺热咳喘颗粒 含量测定 方法转换 

分 类 号：R917[医药卫生—药物分析学]